Howmedica Osteonics Recalls Triathlon TS Plus Tibia Insert for Packaging Breaches
Howmedica recalls Triathlon TS Plus Tibia Insert (model X3 POLY 11 MM) due to potential packaging breaches that could compromise sterility. Affected units sold between 2023-2028.
Lower-risk recall
Potential packaging breaches of inner blister and outer sterile blister.
Contact the company
What happened, in plain English
Howmedica is recalling its Triathlon TS Plus Tibia Insert (model X3 POLY 11 MM) because the packaging might not seal properly, risking contamination. This could affect surgical implants if the sterile packaging is compromised during use. Read more at govinfonow.com/recall/56188-howmedica-osteonics-recalls-triathlon-ts-plus-tibia-insert-for-packaging.
Source Summary by GovInfoNow · govinfonow.com/recall/56188-howmedica-osteonics-recalls-triathlon-ts-plus-tibia-insert-for-packaging · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1264-2024
Cite this page
“Howmedica Osteonics Recalls Triathlon TS Plus Tibia Insert for Packaging Breaches.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/56188-howmedica-osteonics-recalls-triathlon-ts-plus-tibia-insert-for-packaging. Based on FDA recall #Z-1264-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1264-2024%22&limit=1).
Why it’s dangerous
The packaging may breach, allowing contaminants to enter the sterile environment. This could lead to infection if the implant is not properly sterilized before use. However, the risk is low as this is a packaging issue, not a direct defect in the implant itself.
Who’s affected
Surgical patients who received this specific implant model during procedures between 2023 and 2028. Patients using the product for orthopedic procedures are most at risk.
How to tell if you have this one
Check for the model name 'X3 POLY 11 MM' on the packaging. The product was sold with part number 5537-G-411-E and lot number E97TH6 between 2023 and 2028.
- Brand
Howmedica- Product
NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM- Category
Medical device
All 8 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| Z-1259-2024 | X3 TRIATHLON CS INSERT NO 3 10 MM; Part No. 5531-G-310-E; GTIN: 07613327390544; Lot No. 313JA9, 8711AV, A4462V, XD1AT4, MR77W5, TD5KL3, H97AME, YW30KL; Expiration Date: 10/07/2028. | 132 units (US); 26 units (OUS) |
| Z-1260-2024 | X3 TRIATHLON CS INSERT NO 6 10 MM; Part No. 5531-G-610-E; GTIN: 07613327390575; Lot No. 1L0WAY, 323EAY, A72D9D, 9885E1, 9Y397R, L573YP; Expiration Date: 10/07/2028. | 143 units (US) |
| Z-1261-2024 | X3 TRIATHLON CS INSERT NO 6 11 MM; Part No. 5531-G-611-E; GTIN: 07613327337341; Lot No. HL7228; Expiration Date: 11/08/2028. | 24 units (US) |
| Z-1262-2024 | X3 TRIATHLON CS INSERT NO 7 9 MM; Part No. 5531-G-709-E; GTIN: 07613327337464; Lot No. KA1Y71; Expiration Date: 11/08/2028. | 24 units (US) |
| Z-1263-2024 | NO 3 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM; Part No. 5537-G-311-E; GTIN: 07613327288063; Lot No. EP81Y7, YL5VKA; Expiration Date: 10/07/2028. | 39 units (US); 10 units (OUS) |
| Z-1264-2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM; Part No. 5537-G-411-E; GTIN: 07613327287691; Lot No. E97TH6; Expiration Date: 10/07/2028. | 18 units (US); 5 units (OUS) |
| Z-1265-2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM; Part No. 5537-G-416-E; GTIN: 07613327287745; Lot No. H21A0K, XY776E; Expiration Date: 10/07/2028. | 24 units (US); 1 unit (OUS) |
| Z-1266-2024 | NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 16 MM; Part No. 5537-G-513-E; GTIN: 07613327287813; Lot No. 9M3A91, EV0DV0; Expiration Date: 10/07/2028. | 37 units (US); 10 units (OUS) |
What to do — step by step
Check Packaging Integrity
Inspect the inner and outer sterile blisters for signs of damage or breaches.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA distribution: “Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 36 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-1264-2024 (February 6, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1264-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.